| Primary Device ID | 10884450088743 |
| NIH Device Record Key | f93886a0-d7a6-481a-8787-ad22fec8e476 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIG60™ |
| Version Model Number | 00884450088746 |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450088746 [Primary] |
| GS1 | 10884450088743 [Package] Contains: 00884450088746 Package: [5 Units] In Commercial Distribution |
| MAV | Syringe, balloon inflation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 10884450088743 | 00884450088746 |
| 10884450860370 | T |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIG60 85397214 not registered Dead/Abandoned |
THYSSENKRUPP BILSTEIN OF AMERICA, INC. 2011-08-12 |
![]() BIG60 85378311 4111608 Live/Registered |
Merit Medical Systems, Inc. 2011-07-22 |